New recommendations designed to increase early diagnosis of HIV infection as a pathway to improved treatment and prevention

The U.S. Centers for Disease Control and Prevention (CDC) today published new recommendations for health care providers that are designed to make voluntary HIV screening a routine part of medical care for all patients aged 13 to 64. The recommendations aim to simplify the HIV testing process in health care settings and increase early HIV diagnosis among the estimated more than 250,000 HIV-positive Americans who are unaware of their infection. The recommendations also include new measures to improve diagnosis among pregnant women and further reduce mother-to-child HIV transmission. The Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings were published today in CDC’s Morbidity and Mortality Weekly Report (MMWR).

Increasing the proportion of people who know their HIV status is an essential component of comprehensive HIV treatment and prevention efforts in the United States. Early diagnosis is critical in order for people with HIV to receive life-extending therapy. However, today, nearly 40 percent of individuals diagnosed with HIV are diagnosed within one year of infection progressing to AIDS, when it may be too late for them to fully benefit from treatment. Additionally, studies show that most people who learn they are infected take steps to protect their partners, while people who are unaware of their infection are estimated to account for between 50 percent and 70 percent of new sexually transmitted HIV infections.

“We urgently need new approaches to reach the quarter-million Americans with HIV who do not realize they are infected,” said Dr. Julie L. Gerberding, CDC director. “People with HIV have a right to know that they are infected so they can seek treatment and take steps to protect themselves and their partners.”

The new recommendations address HIV screening in health care settings only, and do not apply to non-clinical settings such as community centers or outreach programs. They replace CDC’s 1993 recommendations on testing in acute care hospitals and update the portions of CDC’s 2001 recommendations on HIV counseling, testing, and referral that apply to health care settings.

The new recommendations are designed to overcome several barriers that hindered implementation of the earlier recommendations, which called for HIV testing for patients in health care settings with high HIV prevalence (above 1 percent) and for all high-risk individuals. Implementation of these recommendations was difficult because many health care facilities do not have information on HIV prevalence, and many providers report that they do not have sufficient time to conduct risk assessments. Physicians also report that the processes related to separate, written consent and pre-test counseling for HIV testing have posed significant barriers. In surveys and in consultations held by CDC, health care providers consistently reported these time-consuming processes were not feasible in emergency rooms and other busy health care settings.

“Our goal is to ensure that everyone who receives medical care also has the opportunity to learn if they are infected with HIV,” said Dr. Kevin Fenton, Director of CDC’s National Center for HIV, STD and TB Prevention. “These new recommendations will make routine HIV screening feasible in busy medical settings where it previously was impractical. Making the HIV test a normal part of care for all Americans is also an important step toward removing the stigma still associated with testing.”

Highlights of the new recommendations for health care settings

CDC’s recommendations were developed over a three-year period with extensive input from health care providers, public health experts, community-based organizations, and advocates nationwide. Major components of the new recommendations include:

HIV screening for all patients, regardless of risk: Despite prior CDC recommendations for routine testing for high-risk individuals and for all patients in settings with high HIV prevalence, many patients with unrecognized HIV infection access health care but are never tested for HIV. To normalize HIV screening as a routine part of medical care, the revised recommendations advise that all patients aged 13-64 be screened.

Voluntary, “opt-out” approach: CDC’s recommendations strongly emphasize that HIV testing must be voluntary and undertaken only with the patient’s knowledge. The recommendations advise that patients be specifically informed that HIV testing is part of routine care and have the opportunity to decline testing. Before making this decision, patients should be provided basic information about HIV and the meanings of positive and negative test results, and should have the opportunity to ask questions.

Simplified testing procedures: To overcome the most significant barriers to testing in health care settings, the recommendations advise that pre-test counseling and separate, written consent for HIV testing should no longer be required. Consent for HIV testing can be incorporated into general consent for medical care. Regarding counseling, the recommendations underscore the need to ensure that patients who test positive for HIV are provided prevention counseling and linked to ongoing care. Additionally, CDC continues to encourage prevention counseling for all patients where feasible, especially when the health care visit is related to substance abuse, sexual health, family planning, or comprehensive health assessments.

Enhanced screening for pregnant women: Existing CDC recommendations for routine prenatal HIV screening have already contributed to remarkable success in preventing mother-to-child HIV transmission in the U.S. The estimated number of infants born with HIV declined from a peak of approximately 1,650 in 1991 to fewer than 240 each year today. The new recommendations are intended to help reduce this number even further. They state that repeat HIV testing should be provided in the third trimester not only for women at high risk for HIV, as current recommendations advise, but also for women in areas with high HIV prevalence among women of childbearing age or in facilities with at least one HIV diagnosis per 1,000 pregnant women screened. They also specify that a rapid HIV test should be used during labor for all women whose HIV status remains unknown at the time of delivery.

Next Steps in Implementing the Recommendations

These recommendations are one of many steps that CDC, in conjunction with multiple private and public sector partners, is taking to increase HIV testing in health care settings. CDC will issue additional guidance for health care providers in early 2007, which will provide examples of model approaches and practical tools for implementation in various types of health care settings. CDC is also working with other federal government agencies to ensure that people diagnosed with HIV have access to care.

CDC continues to support the full range of HIV prevention interventions needed to reduce HIV infections in the United States, including comprehensive interventions for both HIV-infected and high-risk individuals. As part of these efforts, CDC believes it is essential to reach everyone with the opportunity to learn whether they are infected with HIV. These recommendations are designed to maximize opportunities for early diagnosis in health care settings, but must be supplemented with innovative approaches to expand testing in community settings and ensure linkages to prevention and care.